The Innovative Regulatory Pathways Summit 2018 covers topics such as:
- Clinical requirements for breakthrough therapy design ation and the impact of receiving designation on trail design/CMC plans
- The expedited drug development options provided by the FDA
- Regulatory strategies to expedite oncology and rare disease product development timelines
- Patient focused drug development to build clinical trial frameworks for breakthrough therapy applications
- Sakigake, PRIME, and Breakthrough Therapy Designation to expedited tracks in non-ICH countries
The Innovative Regulatory Pathways Summit 2018 brings together representatives from pharmaceutical, biotechnology, and medical device companies with responsibilities in:
- Business Development/Strategy
- Regulatory Affairs/Strategy/Operations
- Product Development
- Clinical Operations/Development/Affairs
- Patient Advocacy
- R&D/Drug Development
- Strategic Planning
- HEOR and Outcomes Research
- Oncology Program Management
- Competitive Intelligence
- Pipeline/Portfolio Management
- Rare Disease/Orphan Program Management
- Medical Information/Affairs
- Pharmacovigilance
Also:
- Clinical/Contract Research Organizations
- Regulatory Advisors/Service Providers/Consultants
- Law Firms
- Drug Development Service Providers
- Strategic/Management Consultants
- Preclinical/Analytical Research Organizations
